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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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artimes balloon dilatation catheter BROSMED MEDICAL k141025 09/12/2014
a&d medical ua-651 digital blood pressure monitor A & D CO., LTD. k141160 10/07/2014
neonatal venous hardshell cardiotomy reservior, pediatric venous hardshell cardiotomy reservior, neonatal venous hardhsh MAQUET CARDIOPULMONARY AG k141432 07/07/2014
silverlon island wound dressing ARGENTUM MEDICAL k141573 08/28/2014
bulk fill flowable composite NOVOCOL, INC. k141994 11/14/2014
rapidfret oral fluid assay for cocaine, rapidfret oral fluid cocaine calibrator set, rapidfret oral fluid cocaine control set BIOPHOR DIAGNOSTICS, INC. k142129 07/24/2015
hospira extension set Hospira, Inc. k142433 12/08/2014
e-cube 5 ALPINION MEDICAL SYSTEMS CO., LTD k142733 10/28/2014
kyoling cpr mask with oxygen port and without oxygen port HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. k142764 07/09/2015
eye secret 38 uv aspheric (polymacon) 1-day soft (hydrophilic) contact lens YUNG SHENG OPTICAL CO., LTD. k143190 01/16/2015

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